RP-HPLC Method for the Quantification of Cladribine in Pharmaceutical Formulation

A simple, precise and accurate RP-HPLC method was developed and validated for rapid assay of Cladribine in tablet dosage form. Isocratic elution at a flow rate of 1ml/min was employed on a symmetry Zodiac C18 (250x4.6mm, 5μm in particle size) at ambient temperature. The mobile phase consisted of Methanol: Acetonitrile: Water in the ratio of 64:22:14%, v/v/v. The UV detection wavelength was 231 nm and 20μl sample was injected. The retention time for Cladribine was 5.530 min. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Cladribine in tablet dosage form and bulk drug.